Abstract: An elongate medical device may overcome be configured both for manual manipulation by a physician and for automatic manipulation by a remote catheter guidance system. Such an elongate medical device comprises a shaft having a proximal portion and a distal portion, a pull wire disposed in the shaft and affixed to the distal portion of the shaft, and a handle coupled with the proximal portion of the catheter shaft. The handle comprises a first mechanism configured for manual actuation of the pull wire so as to deflect the distal portion of the shaft, a second mechanism configured for remote actuation of the pull wire so as to deflect the distal portion of the shaft, and a mechanical interface configured to provide a remote catheter guidance system with a functional connection to the second mechanism.

Abstract: A syringe assembly includes a syringe barrel having a first end, a second end, and a sidewall extending between the first end and the second end. The syringe assembly further includes a stopper disposed within a chamber of the syringe barrel, a plunger adapter engaged with the stopper, and a plunger rod having first and second ends. The first end of the plunger rod is pivotally secured to the plunger adapter. The plunger rod has a pre-use position where the second end of the plunger rod is positioned adjacent to the syringe barrel, and a use position where the plunger rod is configured to displace the stopper relative to the syringe barrel. A recessed portion of the plunger adapter receives a portion of the first end of the plunger rod when the plunger rod is in the pre-use position and the use position.

Abstract: According to the invention, a safety device for a pre-filled syringe comprises of a support body adapted to mount the pre-filled syringe, a first needle shield slidably arranged with respect to the support body and a second needle shield slidably arranged with respect to the support body and releasably retained in a retracted position (PR). A proximal movement of the first needle shield with respect to the support body releases the retention of the second needle shield in the retracted position (PR), so that the second needle shield is allowed to slide in the distal direction towards an advanced position (PA).

Abstract: Disclosed herein are devices, systems and methods for using such devices and systems for treating incisions and wounds. In an aspect, disclosed is a device having a generally planar tension relief module and a flexible sealant structure sized to cover the tension relief module, the flexible sealant structure comprising a lower adhesive surface. The tension relief module includes a conduit structure having a plurality of support structures on an upper surface of the conduit structure and at least one opening extending through the conduit structure from a lower surface to the upper surface. At least a portion of the conduit structure is adapted to be aligned with a longitudinal axis of the incision. The tension relief module also includes opposing adhesive structures coupled to the conduit structure. The lower adhesive surface of the flexible sealant structure and the upper surface of the conduit structure form a flow pathway.

Abstract: A process for lyophilizing a solution of an active agent in a container is provided. Solution of active agent is deposited into a container, the container is covered with a covering plate and placed inside a lyophilizing apparatus. Lyophilization can be conducted to dryness by radiation, convection or both. Also provided is a device made by this process, an active agent-plastic administration device (e.g., a syringe), containing an active agent in the form of lyophilized cake, and an array of such administration devices.

Abstract: Provided is a medicament delivery device (100) that is reliable, safe and intuitive to use and at the same time is easy to use when handling. This is achieved by a medicament delivery device (100) comprising a tubular housing (120, 130) having a proximal end (308) and an opposite distal end (309), an actuator member (110) being coaxially arranged at the distal end (309) of the tubular housing (120, 130) and movably arranged, in relation to the tubular housing (120, 130) and a cap (140) being releasably connected to the proximal end (308) of the tubular housing (120, 130) wherein the medicament device (100) further comprises a longitudinal actuator interlocking member (150) movably arranged within the tubular housing (120, 130) and interactively connected to both the actuator member (110) and to the cap (140) for controlling movement of the actuator member (110). Thus the cap (140) acts as a device enabler, i.e.

Abstract: A dispensing device which disperses medicate through a needle across a zone within a body with zero pressure differential. The device includes a needle which is, during use, becomes encapsulated within a tubular needle-receiving member, a therapeutic agent reservoir in fluid communication with the needle, positioned within said housing, and in communication with the needle, a second reservoir, a reservoir-connecting conduit in communication with the therapeutic agent reservoir, a fluid drive in communication with the fluid in the second reservoir and in communication with said reservoir-connecting conduit, and a linear drive attached to said needle or to said needle-receiving member.

Abstract: A medicament container retaining mechanism for a medicament delivery device includes at least one flexible retaining member arranged to a housing part of the medicament delivery device. The housing part is configured to receive a generally tubular medicament container. The at least one flexible retaining member is configured to interact with an outer surface of a received medicament container, exerting lateral clamping forces on the medicament container to prevent movement of the container in a generally lateral direction in the housing part.

Abstract: A system and method for delivering a payload to ocular tissue includes a solution of light-degradable nanoparticles encapsulating the payload. The solution may be introduced to the ocular tissue by way of injection or through a contact lens into which the solution is embedded. A light source delivers a beam of light to the ocular tissue at the location where the solution was introduced to initiate breakdown of the particles, releasing the payload. The light source may be a laser, LED, LCD or arc lamp emitting in the ultraviolet light range.

Abstract: The invention relates to a drug delivery device comprising a container for a product, said container comprising a distal tip having a longitudinal axis A and a channel providing a passageway for the transfer of said product, the outer surface of said distal tip comprising a proximal portion and a distal portion linked to each other by a coupling portion, said proximal portion, distal portion and coupling portion being aligned on said longitudinal axis A, wherein the greatest external diameter of said coupling portion is greater than the greatest external diameter of said distal portion on a length L measured along said longitudinal axis A at least equal to 1 mm. The invention also relates to an assembly comprising such a drug delivery device and an adaptor.

Abstract: Apparatus for loading into an injection device and comprising a syringe and a boot remover. The syringe has a syringe body, a needle and a boot providing a sterile cover for the needle. The boot remover has a body for substantially enclosing the boot and a lip or lips projecting inwardly to engage a junction between the boot and the syringe body. The boot remover also has, at its widest point, substantially the same outer dimension as, or a smaller outer dimension than, the syringe body. The apparatus can be loaded into an injection device through an opening at a distal end of the device such that, when loaded, a portion of the boot remover projects through a proximal end of the device to facilitate removal of the boot remover and boot by a user. This arrangement allows a user to remove the boot from the syringe by holding and pulling on said grip.

Abstract: An injector including a syringe arranged along a longitudinal axis, a removable cover for removable engagement with the syringe and a cover removal assembly including an outer portion which is engagable by a user and is movable axially in a cover disengagement direction along an axial travel path with respect to the longitudinal axis and an inner portion which includes at least one engagement portion which is engagable with the removable cover, whereby axial movement of the inner portion in the cover disengagement direction removes the removable cover from the syringe, at least one of the outer portion and the inner portion being configured such as to provide an axially floating lost motion engagement between the outer portion and the inner portion.

Abstract: The present invention includes syringes with valves. The valves control communication between the interior of a barrel of the syringe and the exterior of the barrel. In syringes that include two valves, the valves may be oriented opposite one another, such that one of the valves may enable fluid to flow into the interior of the barrel of the syringe while preventing fluid from flowing in the opposite direction, while the other valve may enable fluid to flow out of the interior of the barrel while preventing fluid from flowing in the opposite direction. Alternatively, a syringe may include a single valve, which is carried at or near a distal end of its plunger. Methods for using such syringes, including, but not limited to, manual pulsed aspiration methods and manual pulsed delivery methods are also disclosed.

Abstract: A system (10, 200) and corresponding method for introducing a drug delivery device (18, 218) through at least part of a biological barrier starts with the drug delivery device (18, 218) deployed within a channel of a hollow needle (12, 212). The hollow needle is inserted into the biological barrier and the drug delivery device is pushed forward by a suitable plunger. The drug delivery device is preferably anchored to the biological barrier through a radially expanding retention arrangement (36, 36?, 36a), and is preferably filled with a liquid drug after deployment via a filling needle (24, 222) extending within the channel of the hollow needle (12, 212).

Abstract: The present invention provides, among other things, compositions, kits and methods for subcutaneous delivery of lysosomal enzymes for effective treatment of lysosomal storage diseases. In some embodiments, the present invention provides methods for treating Hunter syndrome by subcutaneous administration of a replacement iduronate-2-sulfatase (I2S) protein. In some embodiments, the present invention provides a kit comprising an arrangement of components for subcutaneously administering iduronate-2-sulfatase (I2S) protein.

Abstract: The invention features pharmaceutical compositions, methods, and kits featuring dosing gimens and oral dosage formulations for administration of echinocandin class compounds.

Abstract: A medicine dispensing device includes a single injection molded part having a body and a cover pivotally interconnected by an articulation. The body has an annular base and a cylindrical encasement. The cover has a cylindrical portion and an upper dome-shaped portion. The cover is pivotal about the articulation so as to receive the body for axial alignment of the body and the cover. The dome-shaped portion is provided with cams which during the pivoting of the cover toward the body push down a springed actuator of a primary medicine packaging received in the body and fixed in the body by fastening and locking means, thereby causing release of the medicine in the primary medicine packaging.

Abstract: Provided are methods and devices for interfacing with brain tissue, specifically for monitoring and/or actuation of spatio-temporal electrical waveforms. The device is conformable having a high electrode density and high spatial and temporal resolution. A conformable substrate supports a conformable electronic circuit and a barrier layer. Electrodes are positioned to provide electrical contact with a brain tissue. A controller monitors or actuates the electrodes, thereby interfacing with the brain tissue. In an aspect, methods are provided to monitor or actuate spatio-temporal electrical waveform over large brain surface areas by any of the devices disclosed herein.

Abstract: A medicated module comprising a connecting body configured for attachment to a drug delivery device. A first needle is fixed within the connecting body and an outer body operatively coupled to the connecting body. A needle guard operatively coupled to the outer body and a biasing member positioned between the outer body and needle guard. A second needle fixed within the outer body and a recess within the connecting body defines a reservoir. The reservoir contains at least one dose of a medicament and is configured for fluid communication with the first and second needle.

Abstract: Systems and methods are presented for the visual indication of whether a power injector has discharged fluid from a power injector syringe in a previous medical procedure. In this regard, the systems and methods generally provide for a power injector and a syringe for use with the power injector. The syringe includes a visual indicator that moves between a first state and a second state at approximately the same time that the power injector discharges fluid from the syringe such that an operator may view the change in state.

Abstract: A cartridge holder for a drug delivery device is presented having snap fastening connection means to fasten the cartridge holder to a housing of the drug delivery device, wherein the fastening connection means are provided with at least on basically rectangular window for receiving a locking element of said housing. The invention is further directed to a pen-type injector equipped with a respective snap fastening connection for the cartridge holder.

Abstract: A syringe-based device includes a housing, a pre-sample reservoir, and an actuator. The housing defines an inner volume between a substantially open proximal end portion and a distal end portion that includes a port couplable to a lumen-defining device. The pre-sample reservoir is fluidically couplable to the port to receive and isolate a first volume of bodily fluid. The actuator is at least partially disposed in the inner volume and has a proximal end portion that includes an engagement portion and a distal end portion that includes a sealing member. The engagement portion is configured to allow a user to selectively move the actuator between a first configuration such that bodily fluid can flow from the port to the pre-sample reservoir, and a second configuration such that bodily fluid can flow from the port to a sample reservoir defined at least in part by the scaling member and the housing.

Abstract: The present invention relates to a housing for a drug delivery device, having a first housing component adapted to receive a cartridge at least partially filled with a medicament, and a second housing component adapted to receive a drive mechanism to operably engage with the cartridge for dispensing of a dose of the medicament, wherein the first housing component comprises an insert portion to be inserted in an axial direction into a corresponding receptacle of the second housing component, and wherein the insert portion comprises at least one radially outwardly extending first interlock member to positively engage and to rotationally lock with a correspondingly shaped second interlock member of the receptacle of the second housing component.

Abstract: This invention describes the administration of multiple therapeutic agents with insulin in conjunction with bexarotene, ketamine, monoclonal antibodies Etanercept, IGF-1, and acetylcholine esterase inhibitors physostigmine, for treatment of Alzheimer's disease and other neurodegenerative diseases. Insulin, improves memory; also augments and amplifies the effects of the adjuvant therapeutic agents (paracrine and intracrine effects) and consequently reduces the ? amyloid, its soluble precursors, prevents damage to the neuronal skeletal network (taupathy), and blocks glutamate excitotoxicity, reduces brain inflammation, prevents apoptosis, and increases the acetylcholine levels in the neurons and synapses; by using a combination of insulin, bexarotene, ketamine, Etanercept, IGF-1, and physostigmine therapeutic agents.

Abstract: An injection device is provided for delivering a liquid medicament. The injection device includes a housing with a first chamber for storing a supply of the medicament. The first and second chambers are coupled within the housing. The second chamber is in fluid communication with the first chamber. The injection device also includes an outlet port for dispensing the medicament outside the housing. The outlet port is coupled to the housing and in fluid communication with one of said first and second chambers.

Abstract: Administration devices for supplying an injectable or infusible product into an organism include a reservoir for storing the product, a supply device for supplying the product from the reservoir into the organism, a controller to control operation of the administration device, a button communicatively coupled to the controller to initiate at least one action of the administration device and a touch sensor that generates an activation signal, wherein the touch sensor is incorporated into the button or is disposed in the vicinity of the button and is communicatively coupled to the button and/or the controller.

Abstract: The syringe includes first and second outer cylinders having a flowing port at a distal end through which liquid is flowable, and a plunger inserted from the proximal side of the outer cylinder. The syringe includes a tooth portion provided along the direction of movement of the plunger, and a hook configured to lock the tooth portion at a predetermined locking position and prevent the movement of the plunger in the direction toward the proximal end. The hook retracts from the locking position in association with the unlocking operation and restores automatically to the locking position after the unlocking operation.

Abstract: The present invention is directed to a housing for a drug delivery device. The housing comprises an outer shell with an aperture, an insert received within the aperture and a clamp attached to the outer shell. The insert has at least one recess which is engaged by a lug of the clamp to retain the insert within the aperture of the outer shell. The invention is further directed to a pen-type injector having such a housing.

Abstract: A coded cartridge holder system is disclosed for use with a cartridge assembly (20) containing a fluid and a delivery device (10), where the system has keyed connectors (5, 5?, 6, 6?) to prevent accidental attachment of the wrong fluid delivery device (10). The system comprises a coupling (1) attachable to the dose setting portion (12) of the device (10) and keyed to the proximal end of the cartridge holder (14). The cartridge holder (14) may also contain medical coding (27, 28) to correspond to matching coding (27?, 28?) on the distal end of a cartridge assembly (20).

Abstract: A gasket for use in a syringe so formed as to liquid-tightly and slidably contact an inner surface of an outer cylinder of the syringe, the gasket including a gasket body made of an elastic body and a coating layer formed on a portion thereof which contacts at least the syringe, wherein the coating layer includes a composition containing a silicone resin which comprises a condensate of a reactive silicone resin having a terminal silanol group and which has a siloxane bond derived from the silanol group, and does not contain solid fine particles.

Abstract: The present invention provides an antiseptic cap for use with an access site having a housing with a wall defining a chamber, the wall having a set of threads on an inner surface of the wall; and an access site contacting surface associated with the housing having an antiseptic substance for contacting a surface of the access site. The present invention also provides an antiseptic cap equipped plunger assembly wherein an antiseptic cap is retained within a housing of the plunger.

Abstract: A vial holder is provided to protect a user's hand from needle sticks. The holder includes a handle and a shield attached to a distal end of the handle. An opening is formed in the distal end of the handle to receive a vial. The vial is placed through the opening and into a passageway of the handle with the upper end of the vial exposed. A user grasps the handle which holds the vial in a stabilized manner. A needle may then safely approach the vial in which inadvertent slippage or movement of the needle results in contact with the needle against the shield and not contact with the user's hand.

Abstract: In accordance with at least one exemplary embodiment, a syringe device, a method and a system for delivering a therapeutic amount of ozone are disclosed. A sterility case can enclose a syringe portion and can maintain sterility while the syringe device is interfaced to an ozone generator. A valvably-controlled fluid channel can extend from a barrel of the syringe portion through the case. Conducting elements can be attached to the case and can breach the case. The conductive elements can be connected to electrodes. The electrodes can be attached to the syringe portion. The syringe portion can be filled with oxygen gas via the valvably-controlled fluid channel. An electric current can be provided to the conductive elements from the ozone generator resulting in a corona discharge from at least one of the electrodes. The therapeutic amount of ozone can be produced from the oxygen gas and the syringe portion delivered into a sterile field without compromise.

Abstract: the present invention relates to a medicament delivery device comprising a housing (10), which housing (10) is arranged ranged to accommodate a medicament container (16), the device further comprises a drive mechanism (18) capable of, upon activation, expel a dose of medicament from said medicament container, the drive mechanism comprising a flat spiral spring (26). The invention is characterised in that at least a part (36) of an outermost turn of said flat spiral spring (26) is positioned on an outer surface of said housing (10).

Abstract: An ear medication delivery device for delivering a treatment liquid and retaining the treatment liquid within an ear canal of a patient.

Abstract: Techniques, kits and a delivery instrument for providing a material at a defect repair site. The instrument is a combined delivery needle/elevator/paddle that includes a delivery needle and a paddle/elevator tip attached to the end of the needle and around the most distal opening of the needle. The combined needle/elevator/paddle instrument allows both delivery (insertion or injection) of the material/mixture as well as leveling/flattening of the delivered material. The mixture/material may be micronized allograft tissue such as BioCartilage® and the surgical site may be a defect site such as a microfracture site or cartilage defect.

Abstract: Embodiments of various aspects described herein are directed to silk-based compositions for ocular delivery of at least one active agent, e.g., at least one therapeutic agent and methods of using the same. In some embodiments, the silk-based compositions can provide sustained release of at least one therapeutic agent to at least a portion of an eye. Thus, some embodiments of the silk-based compositions can be used for treatment of an ocular condition, e.g., age-related macular degeneration.

Abstract: Systems, devices, and methods are provided for providing safe syringe assemblies for injections. The syringe assemblies include a shielding mechanism that covers a syringe needle after an injection is delivered, thereby reducing the risk of a subsequent accidental stab from the needle. The shielding mechanism has a pre-injection configuration in which the needle extends beyond the housing and a post-injection configuration in which at least one component of the syringe assembly covers the needle. In some implementations, the syringe assembly includes a lock that inhibits the assembly from returning to the pre-injection configuration once an injection is delivered. The syringe assemblies may also include a bevel orientation mechanism that allows a user to align a needle bevel to accurately insert a needle for injection.

Abstract: A stand for use with a syringe is disclosed. The stand includes a base and a clip affixed to the base. The clip engages a portion of the syringe so as to removably secure the syringe to the stand in a position such that the distal end of the syringe is spaced vertically away from the base. Preferably, the syringe includes a handle extending outwardly from a barrel of the syringe, and the feature which the clip engages includes the handle of the syringe.

Abstract: A pen needle assembly (111) includes an outer shell (151) having a first end adapted to contact a patient's skin at an injection site. A hub (131) is movably disposed within the outer shell. A needle (121) is fixed to the movable hub and has a patient end for piercing the skin at the injection site. An inner shell (171) is disposed within the outer shell and adapted to engage the pen needle assembly with a drug delivery pen (100). A first spring (141) has a first end connected to the outer shell and a second end connected to the inner shell. A second spring (161) has a first end connected to the inner shell and a second end connected to the hub. An adhesive layer (191) is disposed on the movable hub for contacting and raising the skin at the injection site.

Abstract: The autoinjector systems disclosed herein provide in part devices for allowing patients with reduced joint strength to more easily administer medicine. Certain exemplary syringe embodiments include a housing, a syringe assembly slidably mounted on the housing, and a needle cap releasably engaged to the housing, where the cap includes a protruding pocket for receiving a needle cap remover.

Abstract: Injection systems comprising a powered injector and one or more hazardous agents are disclosed.

Abstract: A syringe and needle assembly includes a needle that extends through the barrel of the syringe and is attached to a proximal portion of the syringe. The distal end of the needle extends through a sleeve attached to the distal end of the syringe. The proximal end of the needle includes a spring which biases the needle proximally, so that the distal tip of the needle is normally retracted within the sleeve. The assembly can be used for injections in portions of a patient's body including delicate tissues that could be damaged if contacted by the needle tip.

Abstract: Disposable items made from bioplastic resins include a biodegradable resin selected from the group consisting of polylactic acid (PLA), cellulose based PH, polycaprolate (PCL), polybutyleneadipatetetephathalate (PBT), polyhydroxyalkanoate (PHA), green polyethylene (GPE), green polyethylene terephthalate (GPET), poly-D-lactide (PDLA), and poly-L-lactide (PLLA); a plasticizer intermixed with the resin to provide a generally homogenous bioplastic; and a device formed from the bioplastic, where the device is at least one of a multidose syringe, a sharps container, or a suction canister. Embodiments include green indicators.

Abstract: A syringe for use in the pressurized injection of a fluid. The syringe includes a syringe barrel composed of a polymeric material having undergone expansion via blow molding, and an injection molded attachment mechanism which is integral with the syringe barrel and is located at the proximal end of the syringe barrel. The syringe barrel has a consistent wall thickness and is capable of withstanding pressures of at least 1200 psi. The syringe barrel includes a biaxial stretch sidewall as a result of the blow molding process while the attachment mechanism remains essentially unchanged by the blow molding process. The polymeric material can be, for example, polyethyleneterephthalate, cyclic olefin polymer, polypropylene, polystyrene, polyvinylidene chloride, polyethylene naphthalate and/or nylon.

Abstract: Medicament delivery devices for administration of opioid antagonists are described herein. In some embodiments, an apparatus includes a housing, a medicament container disposed within the housing and an energy storage member disposed within the housing. The medicament container is filled with a naloxone composition that includes naloxone or salts thereof, a tonicity-adjusting agent, and a pH-adjusting agent, whereby the osmolality of the naloxone composition ranges from about 250-350 mOsm and the pH ranges from about 3-5. The energy storage member is configured to produce a force to deliver the naloxone composition.

Abstract: A simple method and device enabling a unit dose from a reservoir is provided. The dose is drawn into the reservoir and is then expelled from the device by depressing a plunger. The plunger has features which divide the dose into discrete intervals. As the plunger is moved during delivery, the features on the plunger and features connected to a barrel interact to provide for intermittent stops to the delivery. Other aspects of the device provide for reduced dead space, safety and selective interconnection with other devices. Thus, the device divides the dose.

Abstract: The present invention relates to a supplementary device a supplementary device for a manually operable injection device. The supplementary device has a body defining a passage through which an injection device is slidable, and a securing unit to secure the body to the injection device in the specific position when the injection device is received through the passage.

Abstract: A liquid embolic material may include a mixture of a first solution comprising between about 1.2% and about 2.5% weight per volume (w/v) carboxymethyl chitosan (CCN) in a first solvent and a second solution comprising between about 1.2% and about 2.5% w/v oxidized carboxymethyl cellulose (OCMC) in a second solvent. The liquid embolic material may be used to embolize a targeted embolization location by mixing the first solution and the second solution to form a liquid embolic material (or hydrogel precursor material), introducing the hydrogel precursor material to a targeted embolization location within a body of a patient, and allowing the CCN and the OCMC to react to form the hydrogel material and embolize the targeted embolization location.

Abstract: The present invention relates to a supplementary device for a manually operable injection device. The device has a body and a mating unit configured to releasably mount the body to the injection device in a specific position relative to an outside surface of the injection device.